Lupus & antiphospholipid syndrome
A Randomized, Placebo‐Controlled Trial of Hydroxychloroquine in Incomplete Lupus
Authors' conclusion
Although the Study of Antimalarials in Incomplete Lupus Erythematosus (SMILE) did not show effects of HCQ on ILE progression, the results offer insights into SLE risk in the ILE population.
Study context
- Population
- Patients 15 to 49 years old with incomplete lupus erythematosus (ANA positivity with one to two additional SLICC criteria)180 analysed
- Participants
- 187 patients
- Comparison
- Hydroxychloroquine (HCQ) vs placebo
- HCQn = 92
- Placebon = 88reference
- Primary endpoint
- Rate of accumulation of SLE features defined by the 2012 SLICC criteria
- Follow-up
- 24 months
Methodological detailsdouble-blind, placebo-controlled, multicentre (seven sites)
- Double-blind
- Placebo-controlled
- Multicentre (seven sites)
Primary result
As reported in the abstract
Acquisition of SLICC criteria
- Rates of acquisition of SLICC criteria similar in the two groups
- HCQ vs Placebo: P = 0.72
Further findings
| Outcome | P value |
|---|---|
| Progression to SLE | P = 0.98 |
- Progression to systemic lupus erythematosus (SLE) — SLE classification developed (of 118 who exited early with SLE or completed 24 months)
- 24 (13.3%)
- Progression to SLE — Developed additional criteria but did not meet classification
- 24
- Progression to SLE — Developed additional criteria (all analysed enrollees)
- 55
Progression to SLE
- Progression to SLE similar in the two groups
Predictors of SLE development
- Development of SLE associated with new malar rash, oral ulcers, joint tenderness, or pleurisy
- P < 0.04
Original publication
A Randomized, Placebo‐Controlled Trial of Hydroxychloroquine in Incomplete Lupus. Arthritis Rheumatol. Published 12 December 2025. doi:10.
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